Just because companies make drugs, should they aspire to less profits than a firm that makes trendy electronic goods?

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by Narayan Ramachandran for Live Mint
For complete article, click here: http://www.livemint.com/Opinion/zqnV2T5dz0XaGITEmSHfqI/Patently-unfair.html

The story of the Supreme Court turning down Novartis’s patent petition for a new and improved Glivec is well known. Less known is that the decision, made on the basis of Section 3(d) of the Indian patent law, is really a technical ruling rejecting the new and improved idea. A patient sympathizer would say the improved notion was merely an attempt by the company to evergreen the drug by extending the patent regime and keeping out generics for longer. A patent sympathizer would say the improved version was truly a more efficacious drug; how is a company to innovate if it cannot protect its innovation? Precisely how a court of law was able to adjudicate on such a technical matter (reasonable experts may well differ) is not clear, but the ruling is binding.
 

The fight is really about the future. It is about how different the future of the pharmaceutical industry will be from its past. It is about the pricing of drugs. It is about how governments will go about balancing patent and patient in a world in which the gap between rich and poor is wide (both within a country and internationally). Could we have a different price for inner city Washington DC, Kenya and India from that in the developed markets? Should the full impact of that differential be borne by the pharmaceutical company or also by the chain of stakeholders—rich consumers, insurance companies and governments? 

HTA/Sustainability of Health Systems in Europe sessons at EuroMeeting2013 - 4-6 March in Amsterdam

Theme 01 - HTA/Sustainability of Health Systems in Europe (7)

• Title: THE EUROPEAN LANDSCAPE ON HTA - THE EUnetHTA JOINT ACTION
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 11:00AM - 12:30PM
• Title: COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 2:00PM - 3:30PM
• Title: HTA AND PRICING POLICIES IN EU AFTER THE TRANSPARENCY DIRECTIVE
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 4:00PM - 5:30PM
• Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: THE PATIENTS’ PERSPECTIVE ON HTA
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: HTA AND OFF-LABEL USE
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM

FDA / CDRH 2013 Strategic Priorities released

Link to: CDRH 2013 Strategic Priorities

The Center for Devices and Radiological Health's (CDRH, the Center) 2013 Strategic Priorities continue and expand upon the work we first started three years ago to reset the direction of the Center towards smart regulation – protecting public health by assuring that devices that enter and remain on the U.S. market are safe and effective, and promoting public health by facilitating device innovation. However, the structure of this year's Strategic Priorities has been re-organized to align with CDRH's Vision, which, along with our Mission and Shared Values, immediately follow this Introduction. You will note that our Vision begins with the word Patients. We intentionally began our Vision with this word because what is at the heart of what we do and what we truly are about is saving the lives, improving the health and enhancing the quality of life of patients and those who one day will or would have been patients.

Although we have re-aligned our Strategic Priorities to support the achievement of our Vision, you will see that the objectives of our 2010-2012 Strategic Priorities² (such as fully implementing a total product life cycle approach) are encompassed within our 2013 plan. In addition, we have kept our earlier Strategic Priority of Strengthening Our Workforce and Workplace in the 2013 plan, consistent with the Center's Shared Value of Our People. A vibrant workforce and workplace are essential to achieving our Mission and Vision.

The primary purpose of CDRH's 2013 Strategic Priorities is to inform the public of some of the most important actions we are committing to implement this year to better understand the direction the Center is heading in and what to expect from us this year. It is not intended as a comprehensive blueprint of every action the Center may take in the coming months.

Lastly, in July 2012, Congress enacted the Food and Drug Administration Safety and Improvement Act (FDASIA)³, which includes reauthorization of the medical device user fee program⁴ and other device-related provisions. We consider implementation of FDASIA to be a top priority for CDRH. Therefore, as a well understood priority, we will implement or begin to implement all of the device-related provisions of FDASIA this year. However, because the FDA has provided a separate mechanism to inform the public of its efforts to implement FDASIA, we have generally not included actions specifically directed at implementing FDASIA in our 2013 Strategic Priorities.

Link to: CDRH 2013 Strategic Priorities

PCORI - Call for Topics and Research Prioritization Methods - Workshops Dec 4 & 5

December 3, 2012 The Patient-Centered Outcomes Research Institute (PCORI) will host workshops tomorrow and Wednesday to solicit input from patients, researchers and other healthcare stakeholders on its draft process for generating and selecting specific research topics. On Tuesday, December 4, PCORI will hold a workshop called " What Should PCORI Study? A Call for Topics from Patients and Stakeholders." The event will solicit recommendations from a diverse group of healthcare stakeholders for specific topics to consider for funding and feedback on PCORI's plans for engaging stakeholders in the research process.   On Wednesday, December 5, the institute will host the "PCORI Research Prioritization Methods Workshop." During this event, research methodologists, patients and other stakeholders will share best practices for improving research prioritization methods and help PCORI refine its proposed prioritization process to see that it addresses the needs of patients and those who care for them.   You can participate in each workshop through:   A free webcast. Register to view both workshops here: www.webcastregister.com/pcori  Tuesday's webcast will be live from 8:00-10:45 a.m. and 3:00-5:00 p.m. Wednesday's webcast will be live from 8:30-11:30 a.m. and 12:30-4:30 p.m. An archive of both workshop webcasts will be available on the PCORI website after the events Join the conversation via Twitter using the #PCORI hashtag. "Suggest a Question" that PCORI can consider as it develops targeted research funding announcements. Submit additional feedback via email to getinvolved@pcori.org. Please visit each workshop event page for more information, including agendas and information on presenters and participants.   ### About PCORI The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.   Patient-Centered Outcomes Research Institute | 1828 L Street, NW | Suite 900 | Washington | DC | 20036

Collaborate to Innovate - #DIA2012 June 24-28 Philadelphia

4 Days. 22 Tracks. 270+ Educational Offerings. 500+ Exhibitors. 7,500+ Attendees. The DIA 2012 48th Annual Meeting offers the most comprehensive and robust learning and networking opportunities to help you find solutions to the challenges you face in the discovery, development, and life cycle management of biopharmaceuticals, biotechnology, medical devices, and related products. Top biopharmaceutical thought leaders will be at the DIA 2012 Annual Meeting to pass on their expertise directly to you. Life Science Entrepreneur Pavilion Network with Entrepreneurs in this year’s new Life Science Entrepreneur Pavilion and discuss how they are changing the future development of new medicines. Pfizer is pleased to support the Life Science Entrepreneur Pavilion at this year’s DIA 2012 Annual Meeting. Funding Funding Innovation and Creating Opportunities in the Device, Diagnostic, and Drug Interface Partnering Models-Public Private Partnerships Pre-competitive Public Private Partnerships: The Changing Model of Pharmaceutical R&D How Industry Can Partner with FDA in Defining a Risk-based Monitoring Program Multistakeholder Development Partnerships: Harnessing Differing Perspectives, Objectives, and Strengths for Success Vaccines Vaccines: FDA and Japan Perspectives Integrated Partnership: A Vaccine Case Study Biotech First-in-human Challenges of Biologics and Biosimilars Product Candidate to Proof-of-concept: An Integrated Approach to Accelerate Programs Regulatory Affairs for Biologics Biomarker Focused Strategies for Personalized Medicine Understanding Comparative Effectiveness Research (CER) in the Biopharmaceutical Industry Other Special Topics Analysis and Impact of PDUFA V: How the Changes Will Affect the Work of Regulatory Affairs Professionals Pediatric Development in the US: Implementation of 2007 PREA and BPCA Against a Backdrop of the EU Pediatric Legislation CBER Town Hall CDER Town Hall: Part 1 of 2 CDER Town Hall: Part 2 of 2 Regulatory Roundtable on Biosimilars Update on Biosimilar Developments in the US Emerging Development and Policy Trends in the Economics of the Biopharmaceutical Industry Risks to and Securing of Global Drug Supply Chains Partnering for Impact in Global Health Executive Program: Pioneering Partnerships Much more! Register Online | Program Overview Group Discounts Available! Register 10 individuals from your company and receive the 11th FREE! Contact your group discount representative for details!

My DIA |

800 Enterprise Road, Suite 200
Horsham, Pennsylvania 19044-3595
T. +1.215.442.6100
F. +1.215.442.6199email: annualmeetingprogram@diahome.org

US Conference on Rare Diseases & Orphan Products: Shaping the Future Now

US Conference on Rare Diseases & Orphan Products

Oct 22 2012 8:00AM - Oct 24 2012 4:00PM
Capital Hilton 1001 16th Street NW, Washington, DC 20036-5794 USA

Co-sponsored with NORD (National Organization for Rare Disorders)

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The Meeting For All Stakeholders in the Rare Disease/Orphan Product Community
This annual meeting where stakeholders - patients, patient organizations, researchers, drug and device companies, investors, thought leaders and government – meet to focus on rare diseases and orphan product research, development and access. At this year’s meeting, we seek to gain a common understanding of the current and emerging challenges, opportunities, and strategies for working together effectively to shape a better future for rare diseases and orphan drugs. It is important to remember none of us can get there alone. The 2011 meeting brought together more than 300 stakeholders, and this year’s event promises even more.

The format of the meeting includes both plenary and smaller group sessions. High-level plenary sessions will open a collaborative dialogue among leading researchers, company officials, investors, patient organizations and government leaders. Smaller group sessions are organized around three central themes: policy, research and regulation and special challenges. These sessions are intended to promote advancements in science, care and other considerations that will address the needs of the 30 million Americans with rare diseases. Topics include the current and emerging drug development environment, reenactment of the Prescription Drug and Medical Device User Fee Act, an update on NIH’s new National Center Advancing Translational Science, and many others.

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Patient Organizations/Patients are invited to attend the US Conference on Rare Diseases and Orphan Products at a reduced registration fee of $400.
Please submit a registration form by fax to 215.442.6199
Questions: Contact Carrie Dunn at the DIA office by telephone 215.442.6181 or email Carrie.Dunn@diahome.org

Who Should Attend

• Researchers from academia and drug and device companies
• Patient organizations and those interested in creating one
• Senior managers from drug and device companies interested in rare diseases
• Investors focused on the future of orphan product development
• Policy experts who are concerned about federal or state policies that affect patients with rare diseases
• Providers of services to the rare disease community, including insurance providers and health care professionals
• Government officials responsible for rare disease research and orphan product oversight